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In the wake of immense success of the
information technology (IT) industry and with a foundation
of knowledge-based industry now firmly established, biotechnology
and clinical research has emerged fast in India. Although
a relatively young market segment, India is looked at
as a favored destination for clinical trials and clinical
validation studies for a number of key factors:
- abundance of patients with ethnic diversity,
- highly trained and experienced medical staff,
- IT-enabled infrastructure, and
- low cost.
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There is a significant economic advantage
in conducting clinical trails in India compared to the
developed countries. Recognizing this potential, Qualtran
has setup facilities for research in India.
India has been a part of the many FDA and EMEA registration
studies. India became a member of WTO in 1995 and agreed
to adhere to the product patent regime by 2005. This has
led to a significant growth in Pharmaceutical Industry
(> 15%) and increased stakes of MNCs in Indian operations.
Qualtran at present is capable of contributing to the
following areas of Clinical Research and Drug Discovery:
Bio-availability, Bio-equivalence Studies, Clinical Trial
Site Management, Clinical Operations management, Multi
Centric Clinical Trials, Central Bioanalytical Lab Facilities,
Data Management, Bio-statistics, report writing and Global
Clinical Trials in Phase I, II, and III. The conduct of
simultaneous successful multi-center global clinical trials
with Indian sites leading in patient recruitment, retention
and completion of all trial related activities, have proved
beyond doubt the choice of India as destination for Clinical
Trials. The advent of reputable bioanalytical laboratory
facilities, their certification and accreditation by national
and international agencies and CAPC (College of American
Pathologists) has added an important crucial dimension
to conduct of clinical trials. No longer there is need
to rush trial samples for analysis to international laboratories
and no longer have time consuming formalities for sample
export and import. |
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